CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 64 enrolled
Drug / intervention
Platelet Rich Plasma plus fat graftingprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04781348
NCT04781348Phase 4Completed

Efficacy of Platelet Rich Plasma Injection Plus Fat Grafting as Compared to Fat Grafting Alone on Burn Scar by Using Vancouver Scar Scale

Dow University of Health Sciences·interventional·Posted Mar 4, 2021·Updated Feb 21, 2023

In Brief

A Phase 4 clinical trial evaluating Platelet Rich Plasma plus fat grafting for Burn. Completed, enrolled 64 participants across 1 site.

Detailed Summary

Background: - Burn injuries always leave behind some permanent marks on the body of a victim. For the treatment of these scars, digital photography along with scar scales instrument are an important instrument for the patient's evaluation and finally for the follow-up of scars. Clinical evaluation of the patient after the use of Platelet concentration that it is a beneficial treatment which affects both on hard and soft tissues healing because of having growth factors deposited in PRP. Therefore, it can be used as an alternative to surgery which promotes safe and natural healing in such patients. Objectives: - 1\. To determine the efficacy of Platelet Rich Plasma plus fat grafting as compared to fat grafting alone on the Vancouver scar scale. Methodology: - An experimental controlled comparison trial study will be done on burn patients, admitted for recovery at the Plastic surgery department, Civil Hospital Karachi after the approval of the scientific committee and Institutional review board of Dow University of Health Sciences, Karachi. The study participants fulfilling the inclusion criteria giving consent will be randomly divided into two groups, one group will receive only fat grafting whereas another group will receive Platelet Rich Plasma plus fat grafting. The sample size of the study will be 52(26 in each group). Both the groups will be followed initially for 15 days of two visits then monthly two visits and finally after 6 months. Assessment of scar with Vancouver Scars Scale (VSS) will be done. The association of the PRP plus fat cells group and control group will be done by applying Chi-square statistical test. P-Value will be set for statistical significance level at \<0.05.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBurn
CountriesPakistan
Collaborators--

Timeline

Phase 4CompletedFinished
20222023202420252026
First PostedMar 4, 2021
Enrollment StartMar 1, 2021
Primary CompletionOct 15, 2021
Study CompletionDec 31, 2021
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 5.3 years ago

Interventions

Platelet Rich Plasma plus fat graftingprocedure

The study participants fulfilling the inclusion criteria giving consent will be randomly divided into two groups, one group will receive only fat grafting whereas another group will receive Platelet Rich Plasma plus fat grafting.